Phase 2
N=138
A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01715896 ↗Enrolled (actual)
138
Serious AEs
3.6%
Results posted
Oct 2016
Primary outcome: Primary: Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 — 65.6; 62.0 percentage of participants — p=0.666
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Golimumab 50 mg (Biological); Mavrilimumab 100 mg (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 |
65.6; 62.0 | 0.666 |
| PRIMARY Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 |
43.4; 34.8 | 0.293 |
| PRIMARY Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 |
25.9; 16.1 | 0.156 |
| PRIMARY Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 |
29.0; 17.4 | 0.108 |
| PRIMARY Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169 |
69.0; 58.7 | 0.2080 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
29; 36; 3; 2; 11; 12 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) |
0; 2; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) |
0; 1; 2; 0 | — |
| SECONDARY Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169 |
1; 0; 4; 1; 1; 0 | — |
| SECONDARY Dyspnea Score at Day 169 |
0.34; 0.42 | — |
| SECONDARY Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169 |
5.72; 5.82; -2.40; -2.11 | — |
| SECONDARY Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 |
40.49; 33.06 | 0.213 |
| SECONDARY American College of Rheumatology (ACR) Hybrid Score at Day 169 |
49.99; 41.66 | — |
| SECONDARY Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 |
12; 16; 28; 35; 28; 19 | 0.129 |
| SECONDARY Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 |
20; 12; 28; 20 | 0.108 |
| SECONDARY Time to Onset DAS28 (CRP) Remission at Day 169 |
57.0; 113.0 | 0.328 |
| SECONDARY Duration of DAS28 (CRP) Remission at Day 169 |
105.0; 69.6 | 0.003 sig |
| SECONDARY Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169 |
19.0; 17.3 | 0.795 |
| SECONDARY Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169 |
18.9; 7.2 | 0.048 sig |
| SECONDARY Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 |
17.6; 5.7 | 0.035 sig |
| SECONDARY Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169 |
8.9; 1.4 | 0.061 |
| SECONDARY Mean Change From Baseline in Swollen and Tender Joint Count at Day 169 |
14.49; 14.07; -10.07; -10.08; 24.93; 25.04 | 0.993 |
| SECONDARY Mean Change From Baseline in Patient Assessment of Pain at Day 169 |
66.93; 69.81; -29.61; -24.72 | 0.272 |
| SECONDARY Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169 |
67.57; 68.53; -28.50; -24.04 | 0.319 |
| SECONDARY Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169 |
6.89; 7.04; -4.28; -4.11 | 0.640 |
| SECONDARY Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169 |
1.58; 1.59; -0.59; -0.40 | 0.055 |
| SECONDARY Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline |
0.5036; 0.5142 | 0.752 |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) at Day 169 |
26.8; 27.8 | 0.725 |
| SECONDARY Serum Concentrations of Mavrilimumab |
0.00; 2837.24; 1084.43; 2094.70; 2886.71; 1731.65 | — |
| SECONDARY Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab |
3; 3 | — |
Summary
The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.
Eligibility Criteria
Inclusion Criteria
- Age 18 through 80 years
- Written consent
- Diagnosis of adult onset Rheumatoid Arthritis (RA) as defined by the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) classification criteria
- Moderately active disease as defined by disease activity score in 28 joints C-reactive protein (DAS28[CRP]) greater than or equal to (>=) 3.2 at screening and DAS28 erythrocyte sedimentation rate(ESR) ≥ 3.2 at Day 1
- Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
- At least 4 swollen joints
- Inadequate response to one or two anti-TNF agents other than the study comparator, as defined by the protocol
- Receiving oral or injectable methotrexate, as defined by the protocol.
Exclusion Criteria
- A rheumatic autoimmune disease or other inflammatory joint disease other than RA
- Previous treatment with biologic therapies other than anti-TNF for RA
- Treatment with other DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs), as defined by the protocol.
- Medical history as defined by the protocol.
Data sourced from ClinicalTrials.gov (NCT01715896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.